Cleared Traditional

K101094 - CLEARJET

K101094 is an FDA 510(k) clearance for CLEARJET, manufactured by Easyglide , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code ODC cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K101094 · Easyglide , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
27d
Days
Class 2
Risk

K101094 is an FDA 510(k) clearance for the CLEARJET. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Easyglide , Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on May 17, 2010 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Easyglide , Ltd. devices

FDA 510(k) Submission Details - K101094

510(k) Number K101094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2010
Decision Date May 17, 2010
Days to Decision 27 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 131d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODC Device Classification - Class 2, Special Controls

Product Code ODC Endoscope Channel Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Give The Endoscope Channel Additional Or Improved Functionality.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - ODC Endoscope Channel Accessory

All 64
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K101094.
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K102409 · Byrne Medical, Inc. · Nov 2010
SCOPE INTRODUCER MODEL 7400
K093329 · N.M. Beale Co., Inc. · Feb 2010
DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)
K090851 · Byrne Medical, Inc. · Jul 2009
SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100
K080764 · Max Endoscopy, Inc. · May 2008